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Enrolling by Invitation

NCT Number: NCT06522958

Effect of Novel High Dissolving Transitional Foods

This is a prospective comparative study, where patients who meet inclusion criteria undergoing a craniofacial procedure will either be provided with novel high dissolving transitional foods for use in the post-operative period (Intervention Group) or will not be provided the food and will proceed as per current standard of care (Standard of Care Group). Both groups will be followed pre-operatively at time of pre-operative visit, and will be followed in the post-operative period, with two visits at 1 and 3 weeks post-operatively, respectively.

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Key information

Conditions

Craniofacial Surgery

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10017, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ages 0 years, 6 months to 18 years of age
  • Patients with a diagnosed cleft/craniofacial condition undergoing one of the following cleft/craniofacial related surgeries in the upcoming calendar year (a-c):
  • Cleft Palate Repair (Palatoplasty)
  • Alveolar Bone Graft Surgery
  • Velopharyngeal Insufficiency Surgery
  • Patients who eat fully by mouth (PO)
  • Patients who adhered to scheduling protocols and attended all necessary pre- and post-operative visits

Exclusion criteria

  • Patients under the age of 6 months or over the age of 18
  • Patients who utilize an NG-tube or G-tube for primary means of nutrition/hydration
  • Patients who have PO recommendations from a licensed Speech-Language Pathologist that prevents their ability to consume Level 4 IDDSI (pureed) foods, including patients who are NPO.
  • Patients with any diagnosed allergies to the ingredients listed on the Savorease Therapeutic Foods ingredient labels
  • Patients/caregivers who are not able to participate in pre- and post-operative protocoled visits for any reason
  • Patients/caregivers who are not able to respond to written questions presented in English

Treatment and study plan

High Dissolving Transitional Food

Dietary Supplement

Transitional foods are solid foods that rapidly change texture in the presence of moisture (e.g., water or saliva) or temperature change. Duration of consumption of the investigational agent will include the time of the surgery until the second post-operative evaluation. This is estimated to be approximately 1-2 months in total.

Primary outcomes

  1. Caregiver-Reported Rating of Feeding Experience

    Time frame: Week 1 Post-Operation (Post-Op)

    Caregivers of participants will complete short survey to assess patient's feeding-related quality of life (QOL) related to the post-operative period. The survey comprises 10 items; each item utilizes a 5-point Likert scale ranging from 0 (Strongly Disagree) to 4 (Strongly Agree). The total score is the sum of responses and ranges from 0-40; lower scores indicate greater feeding-related QOL.

  2. Caregiver-Reported Rating of Feeding Experience

    Time frame: Week 3 Post-Op

    Caregivers of participants will complete short survey to assess patient's feeding-related quality of life (QOL) related to the post-operative period. The survey comprises 10 items; each item utilizes a 5-point Likert scale ranging from 0 (Strongly Disagree) to 4 (Strongly Agree). The total score is the sum of responses and ranges from 0-40; lower scores indicate greater feeding-related QOL.

Secondary outcomes

  1. Number of Participants with Wound Issues at Pre-Op Visit

    Time frame: Baseline (Pre-Op Visit)

    Participants will undergo a wound examination to assess for the presence of fistula, dehiscence, or wound complications.

  2. Number of Participants with Wound Issues at Week 1 Post-Op

    Time frame: Week 1 Post-Op

    Participants will undergo a wound examination to assess for the presence of fistula, dehiscence, or wound complications.

  3. Number of Participants with Wound Issues at Week 3 Post-Op

    Time frame: Week 3 Post-Op

    Participants will undergo a wound examination to assess for the presence of fistula, dehiscence, or wound complications.

  4. 30-Day Readmission Rate

    Time frame: Day 30 Post-Op

    Percentage of participants who are readmitted to the hospital within 30 days post-operation.

  5. Average Participant Weight at Pre-Op Visit

    Time frame: Baseline (Pre-Op Visit)

    Participant weight is measured in pounds (lbs).

  6. Average Participant Weight at Week 1 Post-Op

    Time frame: Week 1 Post-Op

    Participant weight is measured in pounds (lbs).

  7. Average Participant Weight at Week 3 Post-Op

    Time frame: Week 3 Post-Op

    Participant weight is measured in pounds (lbs).

  8. Number of Participants who Self-Report Use of Pain Medicine at Pre-Op Visit

    Time frame: Baseline (Pre-Op Visit)

  9. Number of Participants who Self-Reported Use of Pain Medicine at Week 1 Post-Op

    Time frame: Week 1 Post-Op

  10. Number of Participants who Self-Reported Use of Pain Medicine at Week 3 Post-Op

    Time frame: Week 3 Post-Op

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Comparative Study of the Effects of Novel High Dissolving Transitional Foods on Post-Operative Outcomes for Patients Undergoing Craniofacial Surgery

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 26, 2024
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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